Overview

This course, a Zenosis® eLearning module, outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of an Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drugs User Fee Amendments of 2012 and the law’s effects on generics sponsors. Finally, the different regulatory pathway that applies to the licensure of copies of biological products is described, including the requirements of the Biosimilar User Fee Act of 2012.

The module takes an average of 3.5 hours to complete. (Note that this is an average time. People learn at different rates, and they explore resources and examples at different paces.)